(100 days)
Not Found
No
The description focuses on fixed patterns and computer-guided treatment, not adaptive or learning algorithms. There are no mentions of AI, ML, or related concepts.
Yes
The device is described as a software option for a laser that performs trabeculoplasty in open angle glaucoma, which is a medical procedure to treat a condition.
No
The device description clearly states its purpose is to "simplify the laser trabeculoplasty procedure by applying a fixed pattern of locations to the trabecular meshwork instead of a single spot" and to offer "greater multi-functionality for the management of glaucoma." This indicates a therapeutic function, not a diagnostic one.
No
The device is described as a "software option" for an existing laser system (PASCAL Streamline). While it is software, it functions as an enhancement to a hardware device (the laser) and is not a standalone software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a software option for a laser system used for trabeculoplasty, a surgical procedure performed directly on the eye's trabecular meshwork to treat glaucoma. It applies laser patterns to the tissue.
- No Specimen Analysis: There is no mention of analyzing any biological specimens taken from the patient. The device interacts directly with the patient's eye.
Therefore, based on the provided information, this device falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Pattern Scanning Laser Trabeculoplasty (PSLT) software is intended for use with the PASCAL Synthesis and PASCAL Synthesis TwinStar for procedures in trabeculoplasty in open angle glaucoma.
Product codes (comma separated list FDA assigned to the subject device)
HQF, GEX
Device Description
Pattern Scanning Laser Trabeculoplasty (PSLT) is a software option for the currently marketed PASCAL Streamline (K171488). It represents an enhancement intended to simplify the laser trabeculoplasty procedure by applying a fixed pattern of locations to the trabecular meshwork instead of a single spot. Additionally, this modification offers greater multi-functionality for the management of glaucoma. PSLT provides rapid, defined, uniform and minimally traumatic (sub-visible) computer-guided treatment with exact abutment of the patterns. The patterns readily align to the trabecular meshwork, allowing more rapid and easier applications. Once the software is enabled, the PSLT feature is always available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trabecular meshwork
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The K171488 study was a prospective, randomized, controlled study of patients with open angle glaucoma that required bilateral laser trabeculoplasty for intraocular pressure control. The sample size of 58 eyes was calculated to have sufficient power (at least 80% and two-sided alpha of 0.05) to detect to reject the null hypothesis of an inter-group IOP difference of 3 mmHg with a standard deviation of 3.5 mmHg at 1 month. The chief outcome measure was absolute change in IOP from baseline. Results of the clinical investigation support the indications for use of the PSLT with PASCAL Streamline for procedures in trabeculoplasty in patients with open angle glaucoma by achieving clinical endpoints. Therefore, the clinical study confirms that the device is safe and effective as used according to the instructions for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
change in IOP from baseline to 1-month post-surgery as measured by tonometry and (secondary endpoint) success at 1-month post-surgery as measured by tonometry and CLS derived parameters.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font.
May 25, 2018
Topcon Medical Laser Systems, Inc. Sweta Srivastava Manager, Regulatory and Clinical Affairs 606 Enterprise Ct. Livermore, CA 94550
Re: K180402
Trade/Device Name: PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF, GEX Dated: March 27, 2018 Received: March 29, 2018
Dear Sweta Srivastava:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
Denise L. Hampton -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180402
Device Name
PSLT with PASCAL Synthesis and PASCAL Synthesis TwinStar
Indications for Use (Describe)
Pattern Scanning Laser Trabeculoplasty (PSLT) software is intended for use with the PASCAL Synthesis and PASCAL Synthesis TwinStar for procedures in trabeculoplasty in open angle glaucoma.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
PSLT with PASCAL Synthesis and PASCAL Synthesis TwinStar
K180402
1. Submission Sponsor
Topcon Medical Laser Systems, Inc.
606 Enterprise Ct.,
Livermore,
CA, 94550
USA
Contact: Sweta Srivastava
Title: Manager, Regulatory and Clinical Affairs
2. Date Prepared
May 23, 2018
3. Device Identification
| Trade/Proprietary Name: PSLT with PASCAL Synthesis and PASCAL Synthesis TwinStar | |
|---|---|
| Common/Usual Name: | Laser surgical instrument |
| Classification Name: | Ophthalmic laser/ Powered laser surgical instrument |
| Regulation Number: | 886.4390 and 878.4810 |
| Product Code: | HQF, Ophthalmic laser |
| GEX, Laser surgical instrument for use in general and plastic surgery and in | |
| dermatology. | |
| Device Class: | Class II |
| Classification Panel: | Ophthalmic and General & Plastic Surgery |
4. Legally Marketed Predicate Device(s)
Predicate Device: K171488, PSLT for PASCAL Streamline, Topcon Medical Laser Systems, Inc.
The predicate device has not been subject to a design-related recall.
4
5. Indication for Use Statement
Pattern Scanning Laser Trabeculoplasty (PSLT) software is intended for use with the PASCAL Synthesis and PASCAL Synthesis TwinStar for procedures in trabeculoplasty in open angle glaucoma.
6. Device Description
Pattern Scanning Laser Trabeculoplasty (PSLT) is a software option for the currently marketed PASCAL Streamline (K171488). It represents an enhancement intended to simplify the laser trabeculoplasty procedure by applying a fixed pattern of locations to the trabecular meshwork instead of a single spot. Additionally, this modification offers greater multi-functionality for the management of glaucoma. PSLT provides rapid, defined, uniform and minimally traumatic (sub-visible) computer-guided treatment with exact abutment of the patterns. The patterns readily align to the trabecular meshwork, allowing more rapid and easier applications. Once the software is enabled, the PSLT feature is always available.
7. Substantial Equivalence Discussion
The PASCAL Synthesis and PASCAL Synthesis TwinStar with PSLT option has similar performance characteristics, the same environment of use and patient populations as currently marketed predicate device. As noted in the table, the PSLT software feature in the PASCAL Synthesis and PASCAL Synthesis TwinStar do not raise any different questions of safety or effectiveness as compared to the predicate device.
| Manufacturer | TopCon Medical Laser
Systems, Inc. | TopCon Medical Laser
Systems, Inc. | Device Comparison |
|------------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Trade Name | PSLT for PASCAL
Streamline | PSLT for PASCAL
Synthesis and PASCAL
Synthesis
TwinStar | |
| 510(k) Number | K171488 | -- | -- |
| Product Code | HQF, GEX | HQF, GEX | Same |
| Regulation
Number | 878.4810 and 886.4390 | 878.4810 and 886.4390 | Same |
| Regulation Name | Powered Laser Surgical
Instrument and
Ophthalmic laser | Powered Laser Surgical
Instrument and
Ophthalmic laser | Same |
| Indications for Use | Intended for use with
PASCAL Streamline for
procedures in | Intended for use with
PASCAL Synthesis and
PASCAL Synthesis | Same |
| Manufacturer | TopCon Medical Laser
Systems, Inc. | TopCon Medical Laser
Systems, Inc. | Device Comparison |
| Trade Name | PSLT for PASCAL
Streamline | PSLT for PASCAL
Synthesis and PASCAL
Synthesis
TwinStar | |
| | trabeculoplasty in open
angle glaucoma. | TwinStar for procedures in
trabeculoplasty in open
angle glaucoma. | |
| Output
Wavelength (nm) | 532 (green)
577 (yellow) | 532 (green)
577 (yellow)
638 (red) | Same; PSLT software
feature will not be
implemented in 638 (red)
wavelength. |
| Treatment Laser
Sources | Frequency doubled
solid-state | OPSL: Optically pumped
semiconductor laser;
Diode pumped; solid state | Same |
| Treatment Laser
Power | Up to 2W | 0, 30 mW – 2000 mW
(577)
0 to 600mW (638) | Same; PSLT will not be
implemented in 638 (red)
wavelength. |
| Aiming Beam λ
(power output) | 635 nm; Direct diode
(adjustable to 2.5 dB; no or stable anti-glaucomatous drug therapy since at least 3 months. Exclusion – refractory glaucoma, patients having undergone ocular laser procedures (SLT, LPI) or intraocular surgery for the treatment of glaucoma; corneal or conjunctival abnormality precluding contact lens adaptation; or severe dry eye syndrome.
- . Study Monitoring - primary endpoints were evaluated at the 1, 3, 6, and 12-month endpoint
- . Data Analysis – the modified intent to treat was used in the analysis to the data. Data were analyzed statistically using a 2-tailed unpaired t test, chi-square test, Mann-Whitney U test, repeated-measures analysis of variance. Kaplan-Meier survival analysis with Mantel-Cox logrank test was used to compare outcomes between groups. The sample size of 58 eyes was calculated to have sufficient power (at least 80% and two-sided alpha of 0.05) to detect to reject the null hypothesis of an inter-group IOP difference of 3 mmHg with a standard deviation of 3.5 mmHg at 1 month. The chief outcome measure was absolute change in IOP from baseline.
Results of the clinical investigation support the indications for use of the PSLT with PASCAL Streamline for procedures in trabeculoplasty in patients with open angle glaucoma by achieving clinical endpoints. Therefore, the clinical study confirms that the device is safe and effective as used according to the instructions for use.
The PSLT Software feature's specifications and performance remains unchanged from PASCAL Streamline, PASCAL Synthesis and PASCAL Synthesis TwinStar. Both laser modalities had similar safety and efficacy profiles. Hence, the results of clinical study data for 'PSLT using PASCAL Streamline' support clinical performance of PSLT with PASCAL Synthesis and PASCAL Synthesis TwinStar.
Statement of Substantial Equivalence
The results of the performance testing described above demonstrate that the PSLT with PASCAL Synthesis and PASCAL Synthesis TwinStar are as safe and effective as the predicate device and supports a determination of substantial equivalence.